Apparatus for testing distal colonic and anorectal function

ABSTRACT

In at least one embodiment of a device configured for insertion into a gastrointestinal tract of the present disclosure, the device comprises a core comprising a core material which is solid, semi-solid or compressible, one or more sensors embedded in an interior of the device and/or on a surface of the device, at least one of the one or more sensors configured to obtain a pressure measurement within the gastrointestinal tract and during defecation of the device, and a plurality of electrodes within or upon the device and configured to obtain impedance planimetric measurements within the gastrointestinal tract and during defecation of the device, the impedance planimetric measurements useful to determine cross-sectional areas.

PRIORITY

The present application is related to, and claims the priority benefitof, a) China patent application serial no. ZL 2014 2 0612247.4, filed onOct. 22, 2014, b) U.S. provisional patent application Ser. No.62/239,034, filed on Oct. 8, 2015, and c) U.S. provisional patentapplication Ser. No. 62/243,051, filed on Oct. 17, 2015. The contents ofeach of the aforementioned patent applications are incorporated hereinin their entirety.

BACKGROUND

The function of visceral organs like the gastrointestinal tract, theurinary tract and the heart or blood vessels is to a large degreemechanical. The following introduction refers mainly to thegastrointestinal tract but the invention relates to similar applicationsin other hollow organs such as the urinary tract and the biliary systemin humans and animals.

The gastrointestinal tract is a long tube where ingested food isdigested. Feces is formed from digested contents, from secretions andfrom micro-organisms in the distal part of the gastrointestinal tract.Muscle activity in the wall of the large intestine (so-called highamplitude propagated (contractile) sequences) pushes the fecal contentsmore distal and at some point when it reach the sigmoid colon, theperson or animal feels urge to defecate, go to the restroom and expelthe fecal contents as a voluntary action where the abdominal pressure isincreased, the ano-rectal angle changes, and the anal sphincters relax.The biomechanical properties including the muscle contractile functionand neural circuits (reflexes) are very important for this process.

The Specific Problem and Current Solutions.

The defecatory function is very complex which has two implications, 1)it is difficult to study the process in detail and 2) in many personsdefecation is not functioning the way it should, for example manypatients in China and Worldwide, especially elderly persons, suffer fromconstipation where they have difficulties to defecate. Whereas it isnormal for most persons to defecate every day or every second day,constipated patients may only be able to do it once weekly or even moreseldom.

Constipation can have many courses. For example it relates tohyposensitivity of nerve fibers or to lack of dietary fibers in thefood. Since constipation and also other defecatory problems, such aspain during defecation, fecal incontinence, Hirschsprungs disease,extreme urge to defecate or diarrhea, are frequent diseases in thepopulation, it is of great importance to measure and analyse datarelated to the defecatory process. Disordered defecation andincontinence are associated with significant economic and personalburdens. Our understanding of defecation is incomplete which at least inpart rely on lack of appropriate investigatory tools.

Treatment of defecation problems rely on proper diagnosis. Treatmentscan be surgery, medical treatment or biofeedback. Defecation can bestudied in specialized units in hospitals by means of several methodssuch as pressure recordings (manometry), balloon distension, endoscopy,ultrasonography, and radiographic examinations (defecography). Althoughthese methods provide data on the function, they do not provide goodmeasures of the forces the feces is exposed to and the resultantdisplacements. Most of the methods record only a few parameters and fromone part of the system (for example only from the rectum or from theanal canal). Also symptoms usually do not correlate well to results fromthese tests and therefore the clinical value is limited. Other devicessuch as an ingestible capsula has been commercialised to measure thetransit and pressures during passage from the esophagus to the anus. Thecommercialized capsula may record pressures and pH and may take photosthroughout the passage of the gastrointestinal tract but it has limiteduse for evaluating defecatory function.

It will be an advantage with more advanced technology for diagnosingdisordered defecation. Needless to say for clarifying mechanisms ofdysfunction in patients such a device must make recordings during thepassage from the sigmoid colon to the rectum and the anal canal. Itshould be as natural as possible, in other words imitate the normalfeces and the defecation process, and provide measurements of forces,deformation, location and flow for detailed analysis of the process. Thepreferred embodiment of the present invention is an intraluminal solidor semisolid feces-like device with multiple sensors for analysis of thedefecation process.

BRIEF SUMMARY

The invention consists of an electro-mechanical device thatpreferentially can be inserted into the rectum or colon for studying themechanics of defecation. The device, in various embodiments, issemi-solid, bendable and compressible in order to have the sameconsistency as feces, and it contains a variety of sensors such aspressure sensors, force sensors, deformation sensors, gyroscopes,accelerometers and possible also imaging devices. It also containsenergy supply for the electronic sensors. It may either contain meansfor storage of data or for wireless transmission of data to an externalrecording device. After insertion into the intestine, preferably in thesigmoid colon, the device can be expanded and decoupled from theinsertion device. When the person being studied feels an urge todefecate, he or she will expel it. During this process the device canmeasure a variety of parameters such as pressure profiles, compressionstrain, bending, orientation, location, acceleration and flow, providingvery detailed data on the defecation process. Detailed analysis of thedata can be done by means of software programs. The distribution ofsignals, the shape of the device and position may be used to generate agraphical image of the passage of the device in the distal colon, rectumand anal canal.

In at least one embodiment of a device configured for insertion into agastrointestinal tract of the present disclosure, the device comprises acore comprising a core material which is solid, semi-solid orcompressible, one or more sensors embedded in an interior of the deviceand/or on a surface of the device, at least one of the one or moresensors configured to obtain a pressure measurement within thegastrointestinal tract and during defecation of the device, and aplurality of electrodes within or upon the device and configured toobtain impedance planimetric measurements within the gastrointestinaltract and during defecation of the device, the impedance planimetricmeasurements useful to determine cross-sectional areas.

In at least one embodiment of a device configured for insertion into agastrointestinal tract of the present disclosure, the device furthercomprises a central support that stabilizes and supports the devicewhile providing bending flexibility for the device to have comparablemechanical properties to normal feces.

In at least one embodiment of a device configured for insertion into agastrointestinal tract of the present disclosure, the device furthercomprises an outer sizable structure comprising a bag or balloon aroundthe core and configured to retain liquid or gas therein.

In at least one embodiment of a device configured for insertion into agastrointestinal tract of the present disclosure, the central support isstiff or bendable. In at least one embodiment of a device configured forinsertion into a gastrointestinal tract of the present disclosure, thecore is compressible.

In at least one embodiment of a device configured for insertion into agastrointestinal tract of the present disclosure, the central support,the core, or the outer sizable structure are at or between 3-10 cm long.

In at least one embodiment of a device configured for insertion into agastrointestinal tract of the present disclosure, the device furthercomprises one or more additional sensors selected from the groupconsisting of force sensors, strain gauges, location sensors,gyroscopes, bending sensors, deformation sensors, accelerometers, andcameras.

In at least one embodiment of a device configured for insertion into agastrointestinal tract of the present disclosure, the central support,the core, or the outer sizable structure are at or between 3-10 cm long,

In at least one embodiment of a device configured for insertion into agastrointestinal tract of the present disclosure, the device furthercomprises one or more additional sensors selected from the groupconsisting of pressure transducers, force sensors, strain gauges,location sensor, gyroscopes, bending sensors, deformation sensors,accelerometer, and miniature cameras for measurement of organ function.

In at least one embodiment of a device configured for insertion into agastrointestinal tract of the present disclosure, the device furthercomprises an energy source.

In at least one embodiment of a device configured for insertion into agastrointestinal tract of the present disclosure, the device furthercomprises a data storage unit.

In at least one embodiment of a device configured for insertion into agastrointestinal tract of the present disclosure, the device furthercomprises a wireless transmission unit configured to communicate with anexternal receiver.

In at least one embodiment of a device configured for insertion into agastrointestinal tract of the present disclosure, the device forms asystem along with a display, a signal conditioning unit, and an analysisunit, wherein data obtained from the one or more sensors and/or theplurality of electrodes can be analyzed in terms of trajectories, forcedistributions, bending, angling, color contour plots, and/or 3D(three-dimensional) graphics, for transit function in an organ.

In at least one embodiment of a device configured for insertion into agastrointestinal tract of the present disclosure, the device isconfigured for placement within the sigmoid colon or rectum and wherethe core material and the surface of the device have comparableproperties to feces.

In at least one embodiment of a device configured for insertion into agastrointestinal tract of the present disclosure, the device comprises avalve configured to connect to a tube, the tube used to provide theouter sizable structure with the liquid or the gas.

In at least one embodiment of a device configured for insertion into agastrointestinal tract of the present disclosure, the device furthercomprises an attachment configured to permit an individual inserting thedevice into the gastrointestinal tract to push or pull the device to apreferred location.

In at least one embodiment of a device configured for insertion into agastrointestinal tract of the present disclosure, the device isconfigured to be inserted into the gastrointestinal tract using anintroducer that will be withdrawn from the device before operation ofthe device within the gastrointestinal tract.

In at least one embodiment of a device configured for insertion into agastrointestinal tract of the present disclosure, the device comprises along and narrow configuration.

In at least one embodiment of a device configured for insertion into agastrointestinal tract of the present disclosure, the device furthercomprises one or more electrical stimulating sensors thereon, the one ormore electrical stimulating sensors configured to deliver an electricalsignal to a portion of the gastrointestinal tract.

In at least one embodiment of a device configured for insertion into agastrointestinal tract of the present disclosure, the device furthercomprises a battery or energy source connected via wires to the one ormore sensors and to the plurality of electrodes.

In at least one embodiment of a device configured for insertion into agastrointestinal tract of the present disclosure, the device furthercomprises a stabilizing flexible or non-flexible core rod.

In at least one embodiment of a device configured for insertion into agastrointestinal tract of the present disclosure, the device furthercomprises a stabilizing flexible or non-flexible core rod.

In at least one embodiment of a device configured for insertion into agastrointestinal tract of the present disclosure, the battery or energysource is coupled to the stabilizing flexible or non-flexible core rod.

The present disclosure includes disclosure of use of any of the variousdevice embodiments of the present disclosure.

In at least one use of an exemplary device of the present disclosure,the outer sizable structure can be inflated at different pressuresand/or volumes and wherein diameters of the outer sizable structure canbe recorded at the different pressures and/or volumes.

In at least one use of an exemplary device of the present disclosure,the diameters can be recorded as a circumference and a tension toproduce a tension-length relation.

In at least one use of an exemplary device of the present disclosure,pressure measurements and impedance measurements can be obtained by thedevice within the gastrointestinal tract and during defecation of thedevice.

In at least one use of an exemplary device of the present disclosure,the pressure measurements and/or the impedance measurements obtainedwithin the gastrointestinal tract and/or during defecation of the devicecan be used to diagnose a gastrointestinal condition.

In at least one use of an exemplary device of the present disclosure, alength (from circumference or diameter) and tension (from the product ofpressure and diameter) can be determined using measurements obtained bythe device.

BRIEF DESCRIPTION OF THE DRAWINGS

The disclosed embodiments and other features, advantages, anddisclosures contained herein, and the matter of attaining them, willbecome apparent and the present disclosure will be better understood byreference to the following description of various exemplary embodimentsof the present disclosure taken in conjunction with the accompanyingdrawings, wherein:

FIGS. 1A, 1B, and 1C: Sketches of the smart artificial pellet (anexemplary device or apparatus of the present disclosure) inside theintestine at different locations. In FIG. 1A the device is shown in thesigmoid colon immediately after insertion. In FIG. 1B the device ispassing down into the rectum and the anorectal angle is changed as itdoes during defecation. In FIG. 1C the device is about to be expelledthrough the anal canal. The elements as shown in these figures include1: smart artificial pellet device (SAP), 2: anal sphincter, 3: rectum,4: sigmoid colon, and 5: anorectal angle.

FIGS. 2A, 2B, 2C, and 2D: Sketches of different embodiments of the smartartificial pellet, in all of them various sensors are shown and otherelectronic components such as energy supply, memory unit, andtransmitter. In FIG. 2A the artificial fecal pellet has a stabilizingflexible core in the interior which allows it to bend in differentdirections. In FIG. 2B an embodiment is shown without the centralstructure. FIG. 2C shows an embodiment with an outer balloon that can beinflated until the patient feel urge to defecate or experience othersymptoms. FIG. 2D shows the connecting tube and an exemplary valve thatis used during filling of the balloon. When the tube is disconnected,the valve secures that the fluid inside the balloon does not leak out.FIG. 2D also illustrates a loop structure at the tip which can be usedfor the doctor to drag the artificial fecal pellet with an endoscope upto the preferred location. The elements as shown in these figuresinclude 6: central stabilizing flexible or non-flexible core rod, 7:pellet solid or semi-solid material, 8: sensors embedded in the interiorof the artificial fecal pellet, 9: sensor on the surface or theartificial fecal pellet, 10: battery or energy source connected throughwires to all sensors, transducers and transmitter, 11: data storagedevice or wireless transmitter to outside unit, 12: distensible shelllike a balloon or bag that can be inflated, 13: liquid or gas inside theshell, 14: electrodes for impedance planimetric measurement ofcross-sectional areas, 15: loop that the endoscope can attach to duringinsertion, 16: valve, and 17: tube for filling the outer structure suchas a balloon.

FIG. 3 shows a sketch of a system showing the smart artificial pellet, areceiver unit outside the body and a computer or other unit for storage,analysis and display of data. The elements as shown in this figureinclude 7: pellet solid or semi-solid material, 8: sensors embedded inthe interior of the smart artificial pellet, 9: sensor on the surface orthe smart artificial pellet, 10: battery or energy source connectedthrough wires to all sensors, transducers and transmitter, 11: datastorage device or wireless transmitter to outside unit, 18: wirelesstransmission to unit outside the body, 19: receiver unit with or withoutdisplay; 20: wireless or wired transmission to computer or analysisunit, and 21: computer or analysis/graphics unit.

FIG. 4 shows an additional embodiment of the smart artificial pellet,having a relatively long and narrow “worm-like” configuration which canbe swallowed by the patient or inserted by endoscope or surgery. Theelements as shown in this figure include 1: smart artificial pelletdevice (SAP), 6: central stabilizing flexible or non-flexible core rod,7: pellet solid or semi-solid material, 8: sensors embedded in theinterior of the artificial fecal pellet, 9: sensor on the surface or theartificial fecal pellet, 10: battery or energy source connected throughwires to all sensors, transducers and transmitter, 11: data storagedevice or wireless transmitter to outside unit, and 14: electrodes forimpedance planimetric measurement of cross-sectional areas.

FIGS. 5A and 5B show different embodiments of the smart artificialpellet. In FIG. 5A the pellet further comprises one or more electricalstimulating sensors on the surface of the artificial fecal pellet. FIG.5B shows an embodiment without a distensible shell like a balloon or bagthat can be inflated, whereby the sensors embedded in the interior ofthe artificial fecal pellet, the battery, and the data storage device orwireless transmitter to outside unit are positioned on or within thecentral stabilizing flexible or non-flexible core rod. The elements asshown in these figures include 6: central stabilizing flexible ornon-flexible core rod, 7: pellet solid or semi-solid material, 8:sensors embedded in the interior of the artificial fecal pellet, 9:sensor on the surface or the artificial fecal pellet, 10: battery orenergy source connected through wires to all sensors, transducers andtransmitter, 11: data storage device or wireless transmitter to outsideunit, and 22: electrical stimulating sensor on the surface of theartificial fecal pellet.

FIGS. 6A and 6B show different embodiments of the smart artificialpellet. In FIG. 6A the pellet further comprises at least one sensorconfigured as a camera and a light source, such as a flash, so toprovide light so that the camera can obtain images within the patient.FIG. 6B shows an embodiment whereby the smart artificial pellet can makemovements and thereby crawl in a direction within the body, such as upthe colon, using a movement device and a motor. The elements as shown inthese figures include 6: central stabilizing flexible or non-flexiblecore rod, 7: pellet solid or semi-solid material, 8: sensors embedded inthe interior of the artificial fecal pellet, 9: sensor on the surface orthe artificial fecal pellet, 10: battery or energy source connectedthrough wires to all sensors, transducers and transmitter, 11: datastorage device or wireless transmitter to outside unit, 23: sensorconfigured as a camera, 24: light source, such as a flash, 25: movementdevice, and 26: motor.

FIGS. 7A and 7B show different embodiments of the smart artificialpellet. In FIG. 7A the pellet further comprises a bag or balloonpositioned around the front and rear (proximal and distal) sensorsconfigured as pressure transducers in order to measure a more reliablepressure during expulsion, such as shown in FIG. 1C. FIG. 7B shows anembodiment whereby certain components (the battery or energy source andthe data storage device or wireless transmitter shown as exemplarycomponents) are external to the pellet but connected to the pellet usingthin wires. The elements as shown in these figures include 6: centralstabilizing flexible or non-flexible core rod, 7: pellet solid orsemi-solid material, 8: sensors embedded in the interior of theartificial fecal pellet, 9: sensor on the surface or the artificialfecal pellet, 10: battery or energy source connected through wires toall sensors, transducers and transmitter, 11: data storage device orwireless transmitter to outside unit, 27: bag or balloon positionedaround a sensor; 28: liquid or gas inside the bag or balloon; and 29:wire.

FIGS. 8A and 8B show different embodiments of the smart artificialpellet. In FIG. 8A the pellet further comprises an application-specificintegrated circuit (ASIC) or printed circuit whereby one or more of theembedded sensor, the battery or energy source, the data storage deviceor wireless transmitter, and/or the electrodes for impedancemeasurements, are positioned thereon and/or otherwise coupled thereto.Such embodiments can comprise a processor configured to process thevarious types of data obtained using the various sensors and/orelectrodes, and that data (processed and/or raw) can be stored within astorage medium, such as memory, of the device. FIG. 8B shows anembodiment whereby one or more magnets or magnetically-attractiveelements can be used so to magnetically attach to an endoscope duringinsertion and/or to the tube for filling the outer structure such as aballoon. The elements as shown in these figures include 6: centralstabilizing flexible or non-flexible core rod, 7: pellet solid orsemi-solid material, 8: sensors embedded in the interior of theartificial fecal pellet, 9: sensor on the surface or the artificialfecal pellet, 10: battery or energy source connected through wires toall sensors, transducers and transmitter, 11: data storage device orwireless transmitter to outside unit, 12: distensible shell like aballoon or bag that can be inflated, 13: liquid or gas inside the shell,14: electrodes for impedance planimetric measurement of cross-sectionalareas, 16: valve, 17: tube for filling the outer structure such as aballoon, 30: application-specific integrated circuit or printed circuit,31: processor, 32: storage medium; and 33: magnet ormagnetically-attractive element.

An overview of the features, functions and/or configurations of thecomponents depicted in the various figures will now be presented. Itshould be appreciated that not all of the features of the components ofthe figures are necessarily described. Some of these non-discussedfeatures, such as various couplers, etc., as well as discussed featuresare inherent from the figures themselves. Other non-discussed featuresmay be inherent in component geometry and/or configuration.

DETAILED DESCRIPTION

For the purposes of promoting an understanding of the principles of thepresent disclosure, reference will now be made to the embodimentsillustrated in the drawings, and specific language will be used todescribe the same. It will nevertheless be understood that no limitationof the scope of this disclosure is thereby intended.

An object of the present disclosure is to record important physiologicaland pathophysiological parameters during defecation and to overcomedisadvantages of conventional technologies. The various figures showseveral preferred embodiments of the invention. However, the shownembodiments in the figures are merely examples of embodiments. Otherembodiments can be either more advanced or simplifications of theillustrated examples. Various embodiments of the invention include anelectromechanical device to be inserted into a part of thegastrointestinal tract, preferable in the sigmoid colon with the purposeof recording parameters before and during defecation (in the remainingpart of the document the electromechanical device is called smartartificial pellet or abbreviated SAP). The SAP consists in the preferredembodiment of one, two, or all of the following:

a) A central support that stabilizes and supports the whole device butyet provides the needed bending flexibility for the smart artificialpellet to have comparable mechanical properties to normal feces.

b) The core of the artificial fecal pellet where the core material canbe solid or preferably semi-solid in order to make the pellet asphysiological as possible. In other words, the SAP may be compressibleand bendable as normal feces. Several electronic devices such aspressure sensors, force sensors, deformation sensors, accelerometers,gyroscopes, position sensors, miniature cameras and other devices can beembedded in the surface or in the interior of the core material forrecording of relevant data variables such as position, velocity,acceleration, trajectory, pressure distribution, force and deformation.The list of sensors is not complete, basically the device can containany sensor that is small enough to be embedded in the pellet. The corematerial or the central support may also contain an energy source like abattery and storage unit or wireless transmitter for data recorded bythe sensors. The core material may be expandable and compressibleaccording to which solution is best and the surface may be customized toobtain an optimal geometry and surface. For example, in an embodimentwhere the outer structure as mentioned below is not implemented, it willbe preferable that the surface properties of the core imitate thesurface properties of feces with respect to shear stress, viscosity andresistance to flow. Typically the core will be 2-10 cm long and 1-6 cmin diameter after insertion into the intestine but in some embodimentsit may have other dimensions, both smaller or larger.

c) An outer sizable structure that in preferred embodiments is a bagembracing the core material and containing liquid or gas. In preferredembodiments the diameter of the structure after expansion is 3-10 cm indiameter but it may be smaller or larger in some embodiments. Thepurpose of expanding the structure is to create a size that isphysiological after insertion and to create an urge to defecate.Needless to say the SAP may be smaller or larger and not necessarilyspherical or elliptical, it can take any other preferred shape accordingto the design of the structure. The bag material may be customized toobtain an optimal geometry and surface. For example it will bepreferable that the surface properties imitate the surface properties offeces with respect to shear stress, viscosity and resistance to flow.

In a preferred embodiment the SAP is 3-10 cm long, flexible in bending,and compressible in various directions in order to imitate normal feces.The device is comprised of a wireless intraluminal solid or semisolidbolus recording multiple signals such as pressures, forces, deformation,location, velocity acceleration, and direction. From one and up toseveral hundred sensors may be imbedded in the SAP to provide a detailedanalysis of the defecation process, including geometry, location, andthe forces the device is exposed to. The device can contain gyroscopesfor data on the orientation, e.g. in both ends of the device to providedata on angling. The SAP may in preferred embodiments also containsensors for tracking in a scanner or similar device. An exemplaryembodiment is electromagnetic sensors that can be tracked to provide atrajectory of the path the bolus follows during the passage in thesigmoid colon and rectum during defecation. The displacement datatogether with the detailed distribution of surface parameters willprovide multiple options for analysis of the system properties, e.g.color contour graphs of the bolus in relation to the displacement of it.The device will in preferred embodiments contain wireless datatransmission units, memory for data storage, and energy source like asmall battery.

Some sensors in the SAP may be force or deformation sensors based onstrain gauge technology. They may also be based on measurement ofelectrical impedance in an impedance planimetric chamber system formeasurement of cross-sectional area or diameter, or a system based onlight (wave displacement or frequency). One solution is the use ofpressure transducers embedded in the surface. The invention is howevernot restricted to the above solutions, i.e. they may be based on othertechnologies. It is noted that the electrodes used to obtain impedancemeasurements can include electrodes used to excite an electric field andelectrodes (positioned within the excitation electrodes, namely theelectrodes used to excite the field) used to detect the electric fieldso to obtain the impedance measurements, whereby said measurements canbe used to determine cross-sectional area, diameters, and the like.

The sensors are connected with wires or wireless to one or more dataacquisition systems that will amplify and condition the signals.Software (included within various hardware elements of the presentdisclosure, as appropriate, such as stored on a storage medium andaccessed using a processor, on a data storage device, and/or includedwithin various elements shown in FIG. 3) will be used for display andanalysis, for example of color contour plots or other plots showing thepassage of the device and the SAP geometry, anddisplacements/deformation. The data can be related to other recordedsignals or to the stimulation magnitude imposed by various means.

The uniqueness of the invented SAP is that it has completely differentpurpose, structure and content than other known technologies formeasurement inside the gastrointestinal tract. Technologies such ascatheters with pressure sensors as used in high-resolution manometry andradiographic methods such as defecography are obviously very different.Ingestible capsules have been marketed with the purpose of measuringpressure and pH and for photographing the gastrointestinal tract frominside. Such capsules are however rather small and are not expandableand without sensors for measurement of force-deformation relations andthese capsules do not provide detailed data on the defecation process.

The preferred target organ is the sigmoid colon and rectum but it mayapply to any part of the gastrointestinal tract and even to otherorgans. The device must be sized according to the size of the organ tobe placed in. The abovementioned embodiments and figures are merelyexamples, i.e. the listing is not exclusive and many variants of thedevice may be produced, manufactured and commercialized. FIGS. 1-3 showseveral examples of embodiments. Various SAP embodiments can be usedmultiple times with multiple patients, whereby new sterile balloons orbags, such as shown in FIG. 2C, could be used prior to re-use of thedevice.

Additional embodiments of a SAP of the present disclosure can have arelatively long and narrow “worm-like” configuration which can beswallowed by the patient or inserted by endoscope or surgery. Such anembodiment can pass the entirety or part of the gastrointestinal tract.Such an embodiment may be the same or approximately the same length asother embodiments, or it may be longer, whereby the electrodes canobtain impedance data along a greater overall length of the SAP as maybe desired.

Various SAP embodiments can also have one or more electrical stimulatingsensors on the surface of the artificial fecal pellet. These electricalstimulating sensors can electrically stimulate (deliver an electricalsignal to) portions of the gastrointestinal tract, such as thegastrointestinal wall and/or nearby nerves, such as the pudendal nerveclose to the rectum, as pudendal nerve stimulation initiates therecto-anal inhibitory reflex. Additional SAP embodiments can operatewithout a distensible shell like a balloon or bag that can be inflated,whereby the sensors embedded in the interior of the artificial fecalpellet, the battery, and the data storage device or wireless transmitterto outside unit are positioned on or within the central stabilizingflexible or non-flexible core rod. Such embodiments can have a series ofpressure sensors on the core to provide for high-resolution manometryduring the passage of the device through the gastrointestinal tract.

Various SAP embodiments can further comprise at least one sensorconfigured as a camera and a light source, such as a flash, so toprovide light so that the camera can obtain images within the patient.SAP embodiments can also be configured to make movements, and therebycrawl, through portions of the gastrointestinal tract, such as thecolon, by itself. Furthermore, various embodiments can be used to obtaintension and/or strain data, by way of operation of sensors inside and/oron the surface of the SAP, which can be computed and viewed in real-timeor offline. SAP embodiments can also be used to give a measure of theshear force or shear stress during movement of the SAP through thegastrointestinal tract.

SAP embodiments can also comprise a bag or balloon positioned around thefront and rear (proximal and distal) sensors configured as pressuretransducers in order to measure a more reliable pressure duringexpulsion. In various embodiments, certain components referenced hereincan be external to the pellet but connected to the pellet using thinwires. Such components can be placed outside the anal canal andconnected using the wires passing the anal canal to the device. Variouscomponents, such as the battery and/or wireless transmitter, can be onthe outside and connected to the SAP using wires to save overall spacewithin the device itself.

In various embodiments, the pellet further comprises anapplication-specific integrated circuit (ASIC) whereby one or more ofthe embedded sensor, the battery or energy source, the data storagedevice or wireless transmitter, and/or the electrodes for impedancemeasurements, are positioned thereon and/or otherwise coupled thereto.Various SAP embodiments can also have one or more magnets ormagnetically-attractive elements can be used so to magnetically attachto an endoscope during insertion and/or to the tube for filling theouter structure such as a balloon.

Example of use of the invention. The physician in a specialized unit fordefecatory disorders unpacks the device, make sure the battery ischarged and that the SAP is functioning with recordings to an externaldevice. The patient has beforehand been asked to empty the rectum forfeces. The physician makes an endoscopy in the rectum and sigmoid andduring that procedure the SAP is inserted and pushed or pulled up to thepreferred location. The SAP can be expanded either by pulling it outfrom an embracing structure or by filling the bag until the patientfeels urge to defecate. The physician disconnects the tube to the SAPand pulls it out. This leaves the SAP in the sigmoid colon without anyconnecting wires. The endoscope is slowly pulled out and the patient isallowed to defecate. Measurements are made by the device before andduring defecation and the data may be visualized in real time by thereceiver unit outside the person being studied. Detailed analysis maytake place offline. Simultaneously the patient may record symptoms suchas pain during the process. In case the patient cannot defecate the SAP,then it may be necessary to remove it in due time by endoscopy in aclinic or hospital. The physician or a technician will analyze the dataand based on the analysis proper diagnosis and plan for treatment willbe made. This is one exemplary use of a device of the presentdisclosure, noting that other uses (depending on device configurationand componentry) would be used as referenced herein.

The measurements referenced above (such as various mechanics anddisplacement) may also be dependent upon the diameter of the smartartificial pellet device (SAP) and/or the diameter or size of theinflatable balloon or bag. Each patient has a unique tension-lengthrelation that can be determined by varying the diameter of the SAPand/or the balloon or bag and recording the corresponding tension (suchas by way of pressure sensors). The tension-length relation can becalibrated for each patient to determine the appropriate diameter of theSAP and/or the balloon or bag used for that patient.

For example, the balloon or bag can be inflated at different pressuresand/or volumes, and the diameter of the balloon or bag can be recordedas a circumference (π×diameter) along with the tension(pressure×diameter/2) to produce a tension-length relation. Theresultant curve should be parabolic in shape, with the diametercorresponding to the ascending point of the curve selected for eachpatient. These objective measurements can compliment the subjectivemeasurements referenced below.

Various cross-sectional areas or diameters, as referenced herein, can bedetermined by impedance planimetry. In many cases, the balloon or bagcan be filled until the patient feels the urge or need to defecate (asubjective measurement), and then the tube used to fill the bag can bedisconnected and the patient can then try to defecate the SAP. Tensionand diameter measurements can be obtained during filling and during thedefectation process, and the tension-length properties at varioussensation levels, such as the urge to defecate that the pain threshold,can be obtained as well.

While various embodiments of devices and methods for using the same havebeen described in considerable detail herein, the embodiments are merelyoffered as non-limiting examples of the disclosure described herein. Itwill therefore be understood that various changes and modifications maybe made, and equivalents may be substituted for elements thereof,without departing from the scope of the present disclosure. The presentdisclosure is not intended to be exhaustive or limiting with respect tothe content thereof.

Further, in describing representative embodiments, the presentdisclosure may have presented a method and/or a process as a particularsequence of steps. However, to the extent that the method or processdoes not rely on the particular order of steps set forth therein, themethod or process should not be limited to the particular sequence ofsteps described, as other sequences of steps may be possible. Therefore,the particular order of the steps disclosed herein should not beconstrued as limitations of the present disclosure. In addition,disclosure directed to a method and/or process should not be limited tothe performance of their steps in the order written. Such sequences maybe varied and still remain within the scope of the present disclosure.

1. A device configured for insertion into a gastrointestinal tract, thedevice comprising: a core comprising a core material which is solid,semi-solid or compressible; one or more sensors embedded in an interiorof the device and/or on a surface of the device, at least one of the oneor more sensors configured to obtain a pressure measurement within thegastrointestinal tract and during defecation of the device; and aplurality of electrodes within or upon the device and configured toobtain impedance planimetric measurements within the gastrointestinaltract and during defecation of the device, the impedance planimetricmeasurements useful to determine cross-sectional areas.
 2. A deviceaccording to claim 1, further comprising a central support thatstabilizes and supports the device while providing bending flexibilityfor the device to have comparable mechanical properties to normal feces.3. A device according to claim 1, further comprising an outer sizablestructure comprising a bag or balloon around the core and configured toretain liquid or gas therein.
 4. A device according to claim 2, whereinthe central support is stiff or bendable.
 5. A device according to claim1, wherein the core is compressible.
 6. A device according to claim 1,wherein the central support, the core, or the outer sizable structureare at or between 3-10 cm long.
 7. A device according to claim 1 or 2,wherein the device further comprises one or more additional sensorsselected from the group consisting of force sensors, strain gauges,location sensors, gyroscopes, bending sensors, deformation sensors,accelerometers, and cameras.
 8. (canceled)
 9. (canceled)
 10. A deviceaccording to claim 1, wherein the device further comprises an energysource.
 11. A device according to claim 10, wherein the device furthercomprises a data storage unit and a wireless transmission unitconfigured to communicate with an external receiver.
 12. (canceled) 13.A device according to claim 1, forming a system along with a display, asignal conditioning unit, and an analysis unit, wherein data obtainedfrom the one or more sensors and/or the plurality of electrodes can beanalyzed in terms of trajectories, force distributions, bending,angling, color contour plots, and/or 3D graphics, for transit functionin an organ.
 14. A device according to claim 1, wherein the device isconfigured for placement within the sigmoid colon or rectum and wherethe core material and the surface of the device have comparableproperties to feces. 15.-25. (canceled)
 26. The use of a deviceaccording to claim 3, wherein the outer sizable structure can beinflated at different pressures and/or volumes and wherein diameters ofthe outer sizable structure can be recorded at the different pressuresand/or volumes.
 27. The use of a device according to claim 3, whereinthe diameters can be recorded as a circumference and a tension toproduce a tension-length relation.
 28. The use of a device according toclaim 26, wherein pressure measurements and impedance measurements canbe obtained by the device within the gastrointestinal tract and duringdefecation of the device.
 29. The use of a device according claim 28,whereby the pressure measurements and/or the impedance measurementsobtained within the gastrointestinal tract and/or during defecation ofthe device can be used to diagnose a gastrointestinal condition. 30.(canceled)
 31. An electromechanical device to be inserted into the lumenof a biological organ, the device comprising one or more of thefollowing: a central support that stabilizes and supports the wholedevice while providing the needed bending flexibility for the device tohave comparable mechanical properties to normal feces; and/or a corewhere the core material can be solid, semi-solid or compressible inorder to make the device as physiological as possible; and/or an outersizable structure that in preferred embodiments is a bag embracing thecore material and containing liquid or gas.
 32. A device according toclaim 31, wherein the central support is stiff or bendable.
 33. A deviceaccording to claim 32, wherein the core is compressible.
 34. A deviceaccording to claim 31, wherein the central support, the core, or theouter sizable structure are at or between 3-10 cm long. 35.-40.(canceled)
 41. A device according to claim 31, wherein the devicecomprises a valve configured to connect to a tube, the tube used toprovide the outer sizable structure with the liquid or the gas. 42.-52.(canceled)